Attachment_1_RFP_SOW_09-14-2018_Amend_1_FINAL.pdf

ATTACHMENT 1 RFP#: FDA-SOL-18-1195171 – Amendment 1

Statement of Work (SOW)

U.S. Food and Drug Administration (FDA) / Center for Tobacco Products (CTP) MATLAB Technical Services in Scientific Computing

1. BACKGROUND

The U.S. Food and Drug Administration’s (FDA or Agency) Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (2009). Some of CTP’s authority under this law includes setting product standards, reviewing tobacco product applications (e.g., pre-market and modified risk tobacco product applications), requiring new health warning labels, and establishing and enforcing advertising and promotion restrictions. The Tobacco Contract Act directs CTP to consider the impact of regulatory decisions on the population. A key mission of the Statistics Branch within CTP’s Office of Science (OS) is to oversee the development of several computational modeling and simulation approaches used to assess the impact of regulatory actions on the U.S. population. This includes models commissioned by CTP or submitted with pre-market or modified risk tobacco product applications.

The Statistics Branch is involved in the development, verification, and validation of modeling approaches to assess the impact of regulatory actions. Model approaches include deterministic and stochastic system dynamics models, agent-based models, static and dynamic social network analysis, and statistical modeling that may require large scale simulation and big data analytics. A well-established scientific computing language used in the computer implementation of these types of models is MATLAB. MATLAB is a high-level scientific computing programming language and interactive environment used by scientists for the development and implementation of modeling and simulation in a wide range of modeling frameworks. MATLAB is currently used across all centers within FDA for a wide range of scientific computing applications. MATLAB is developed and marketed by MathWorks, Inc.

MATLAB Object Oriented Programing (OOP) offers a powerful scientific computing environment suitable for the development of user-friendly Graphical User Interface (GUI) which facilitates the deployment of complex modeling and simulation approaches to a general audience of scientists across CTP. For example, many scientists may need to make use of the results of a computational simulation model without having to understand the technical and computer implementation complexities of the model. Once the model is deployed in a validated GUI, the outputs from the model help convey valuable information to assist in research and regulatory activities at CTP.

In addition, MATLAB OOP can be deployed in a High-Performance Computer (HPC) environment. HPC is being used more and more for scientific computing applications. FDA currently hosts three (3) HPC environments which can be used to deploy large scale simulation models. HPC is an integral part of the scientific computing work under development by the Statistics Branch. As such, an in-depth understanding of how MATLAB interacts with HPC environments is critical to CTP’s ability to fulfill its mission.

CTP developed the full architecture of version 2.0.6 of the Athena GUI (Athena)using MATLAB

OOP. Athena is used by CTP statistics branch to run hypothetical scenarios associated with tobacco research and regulatory activities. Athena implements a deterministic system dynamic model to project the impact of regulatory activities on tobacco product user behavior and tobacco-related mortality. At a high level, Athena takes population-level input parameters and executes a deterministic model, based on a system of difference equations, to produce a set of outputs associated with projecting product use behavior and mortality by age, sex, and tobacco use status (e.g., initiation, cessation, dual use) over a period (in years). An innovative feature of Athena 2.0.6 is that it implements a model based on a system (i.e. U.S population) in which a population is exposed to multiple tobacco products, as opposed to a single-product model. Athena 2.0.6 consists of two (2) main components: data/input processing and simulation/computations. The Athena GUI model currently resides on individual scientific laptops at FDA that have MATLAB, and the required MATLAB toolboxes, installed.

CTP needs to be able to run the Athena GUI model in a HPC environment in order to obtain the information from the model quicker than using a normal computing environment. CTP also requires further enhancements of the Athena GUI model in order to successfully fulfill CTP’s mission.

2. OBJECTIVE

The objective of this contract is to obtain the necessary technical services to upgrade the capability of the Athena 2.0.6 GUI to Version 2.1.x by incorporating the new features delineated in Section 4 of this SOW.

3. SCOPE

To meet the objective of this contract, the Contractor shall provide the following support to enhance the current Athena 2.0.6 GUI for population modeling (as delineated in Section 4) for CTP Office of Science’s Statistics Branch:

IT-Project Management Support Technical Programming Support

4. REQUIREMENTS / TASKS

4.1 TASK 1: IT‐Project Management Support

4.1.1 Kick‐off Meeting

The Contractor shall host a Kick-off Meeting within fifteen (15) business days of contract award via WebEx. The purpose of the Kick-off Meeting is to introduce the Contractor staff to the Government and to discuss the requirements of the contract.

The Contractor shall provide a written draft agenda and PowerPoint presentation and/or supplementary written materials to be delivered to FDA no later than ten (10) business days prior to the Kick-off Meeting.

The Contractor shall provide final versions of the Kick-off Meeting agenda and PowerPoint presentation and/or supplementary written materials after Contracting Officer’s Representative’s (COR) review no later one (1) business day prior to the Kick-off Meeting.

The Contractor shall provide meeting minutes from the Kick-off Meeting no later than three (3) business days after the Kick-off Meeting.

4.1.2 Monthly Status Review Meetings

The Contractor shall participate in monthly project management review meetings via WebEx. The Contractor shall provide a monthly project management report no later than one (1) business day prior to each monthly meeting. The project management report shall include the following:

Activities planned for the reporting period Work and deliverables completed during the reporting period Status of ongoing activities Activities planned for the following reporting period Problems, issues, or risks projected or identified Alternatives and/or recommended solution(s) for projected or identified problems or issues Known or projected resource (staff and funding) and schedule impacts Status of project funds including monthly and total expenditures and funds remaining

The Contractor shall provide a written draft agenda detailing the above information to be delivered to FDA within five (5) business days from the schedule of each meeting. The Contractor shall provide the final monthly meeting agenda one (1) business day prior to the monthly meeting. The Contractor shall provide meeting minutes for each monthly meeting three

(3) business days after each monthly meeting.

4.1.3 Weekly Project Meetings

The Contractor shall participate in weekly project meetings via WebEx. For each meeting, the Contractor shall provide a meeting agenda establishing what topics are to be covered during the meeting. The Contractor shall provide the COR with a draft agenda no later than two (2) business days prior to the meeting. The COR will determine if additional items needs to be added to the agenda. The final agenda shall be provided to the COR no later than one (1) business day prior to the start of each meeting. The Contractor shall provide meeting minutes for each weekly project meeting three (3) days after each weekly meeting.

4.1.4 Online Demonstrations of the Athena GUI

The Contractor shall provide three (3) online demonstrations via WebEx on the use of the Athena GUI to FDA CTP staff, which includes scientist/managers working on population modeling and simulation. Each demonstration shall demonstrate how to use Athena to run hypothetical scenarios with input parameters to be provided by FDA-CTP and shall discuss the enhancements to the back- and front-end of the GUI via ULM diagrams. For example, the Contractor shall demonstrate how the end-user can use the new features of Athena.

4.2 TASK 2 – Technical Programming Support

4.2.1 Athena 2.0.6 Enhancements

The Contractor shall utilize an iterative development approach for all work done under this contract. The Contractor shall implement this approach in a manner that large applications are broken down into smaller chunks to allow for design and testing in smaller repeated cycles, which may include adding additional features at each cycle. Government review and acceptance of source MATLAB code throughout the development cycle will detect usability issues, missing requirements, and any necessary design changes early in the process allowing them to be put in place immediately.

The Contractor shall enhance the scientific computing capability of Athena 2.0.6 in MATLAB OOP by performing the following activities:

For all enhancements/updates to Athena 2.0.6, the Contractor shall create all MATLAB OOP objects and classes. The Contractor shall provide diagrams for all developed objects and classes (e.g., Unified Modeling Language (ULM) diagrams).

Collaborate with the FDA COR and Project Manager (PM) to ensure that all modeling components (e.g., transitional probabilities and mortality rates) are developed so that future enhancements to Athena 2.1.x can be incorporated into the code architecture (e.g., objects and classes).

Upgrade Athena 2.0.6’s front-end (i.e., icons, windows, and graphics) to incorporate the following essential inputs and outputs parameters features:

o The end-user shall be able to navigate folders where input parameters are stored and to load these inputs into the Athena GUI.

o The end-user shall be able to graphically check the validity of all input parameters.

o The end-user shall be able to generate summary statistics (i.e., means, standard deviation, proportion) of selected output parameters and/or subgroups.

o The end-users shall be able to produce graphical displays of output parameters, including line plots, pie charts, discrete data plots, and polar plots.

o The end-user shall be able to generate reports for each simulation run by using the

MATLAB Report Generator (e.g., summary statistics by sex and age).

Enable use of data files with extension .csv, open, xpt, and SAS for input parameters. That is, the end-users shall be able to import input parameters in any of these data files.

Enable model outputs to be stored by subgroups defined by race, age, tobacco use status, mortality status, years of simulation, and any combination of these. The end-user shall be able to use MATLAB’s graphics capabilities to graphically display outputs associated with any of these subgroups over the period of the simulation.

Enable graphics capabilities for input validity tests. The end-user shall be able to graphically test the validity of the inputs data from the front-end capabilities of the GUI.

Enable relapse to be modelled as a function of time since quitting. For example, via a negative exponential function that the end-user can select from the front-end capabilities of the GUI.

Enable Athena 2.1.x to run in Windows, Linux, and Mac platforms.

Deploy the upgraded Athena GUI into the MATLAB software and document the code development process, including user manuals and ULM diagrams for objects and classes.

The user manuals shall include documentation of new programming functionalities, as well as examples and explanations that detail proper use of the code.

Upgrade Athena 2.0.6 to be compatible for deployment into an HPC environment, incorporating parallel computing and HPC capabilities for large scale simulations in Athena using the MATLAB distributed computing service toolbox and the parallel toolbox.

An example of a large-scale simulation includes running a simulation for sensitivity analysis by sampling from a probability distribution or a hypercube in Euclidian space.

Upgrade Athena 2.0.6 to incorporate features identified by the COR in response to MATLAB OOP challenges identified during the period of performance of this contract (e.g., developing new objects and classes to incorporate new demographic parameters).

Collaborate with the COR to gather and refine model specifications and requirements to apply OOP solutions to both stochastic and deterministic population health models (including any mathematical and statistical programming and use of MATLAB (e.g., techniques for solving systems of stochastic difference and differential equations using MATLAB programing techniques and/or toolboxes)). This shall include the use of Simulink with MATLAB for a numerical solution of systems of stochastic differential equations.

The Contractor shall perform the following tasks to ensure the upgraded Athena GUI meets the front-end and back-end functionality requirements of the SOW:

o Ensure user inputs/outputs requirements associated with each modeling strategy are met.

o Use MATLAB integrated tools to update code, debug applications, and measure computational performance.

o Develop testing and validation strategies for the enhancements to the Athena GUI.

For example, the implementation of the stochastic system dynamic model shall include a testing and validation strategy, such as testing deployment options into MATLAB software.

o Incorporate functionality to store structured data within MATLAB.

Integrate MATLAB (i.e., programming interface) with other programing languages such as C, C++, FORTRAN, Java, R and Python. For example, reusing legacy code (i.e., native code, such as C, C++, etc.) in other languages in MATLAB and calling MATLAB from other languages.

The Contractor shall develop and implement bug fixes to resolve issues they or FDA users discover throughout the implementation of the Athena 2.0.6 enhancements delineated in this SOW (Examples of issues include, but are not limited to, output structure and front-end graphical displays issues).

4.2.2 Documentation

The Contractor shall provide the following documentation associated with the work performed under this contract:

Computer Code: The Contractor shall perform the following for commenting computer code:

o All computer programs relating to the Athena upgrade stated above shall be commented (Human Readable Description) detailing what the code is doing, including the description of any algorithm used to accomplish the objective of the code.

o The Contractor shall make use of MATLAB toolboxes (e.g., MATLAB Report Generator Toolbox, Statistic and Data Mining Toolbox, etc.) to create formatted documentation, including code, comments, and outputs (e.g., graphic displaying inputs and outputs pertaining to parameters).

o All code-related documentation shall be written in a format that can be shared with others (e.g., ULM diagrams). Example documentation includes HTML containing the information about classes and objects in an object-oriented programing setting.

User Documentation: The Contractor shall provide the following documentation delineated below for the end-users. This user documentation shall be written so that individuals new to MATLAB can understand how to use a particular application.:

o Reference Manual: The Contractor shall provide a reference manual explaining the individual features of the code and how they work. For GUI, the documentation shall include description of buttons, tabs, and dialog boxes. It is common in the IT industry to write help files in this format, particularly context-sensitive help that displays a relevant topic whenever a user clicks the help button on a particular screen.

o User Guide: The Contractor shall provide a user guide format explaining how to use an application to perform a particular task. These files shall take the form of a tutorial, with a summary of the tasks to be performed in the introduction and instructions given in numbered steps.

5. DELIVERABLES AND DELIVERY SCHEDULE

SOW

Section #

Deliverable Format Due Date Delivered

To

4.1.1 Contractor to Host Kick-Off

Meeting WebEx 15 business days from date of award.

COR

4.1.1 Draft Agenda/Presentation for Kick-

off Meeting

MS Word, PowerPoint, and/or PDF

10 business days before the date of the Kick-off Meeting.

COR

4.1.1 Final Agenda/Presentation for Kick-

Off Meeting.

MS Word, PowerPoint, and/or PDF

1 business day before Kick-off Meeting.

COR

4.1.1 Kick-off Meeting Minutes. MS Word 3 business days

after the date of the Kick-off Meeting.

COR

4.1.2 Monthly Status Review Meetings. WebEx Every 30

business days after Kick-off Meeting.

COR

4.1.2 Draft Monthly Status Meeting

Agendas.

MS Word 5 business days before monthly meeting.

COR

4.1.2 Final Monthly Status Meeting

Agendas.

MS Word 1 business day before monthly meeting.

COR

4.1.2 Monthly Meeting Minutes. MS Word 3 business days

after monthly meeting.

COR

4.1.2 Monthly Project Management

Report.

MS Word 1 business day before monthly meeting.

COR

4.1.3 Weekly Project Meetings. MS Word Every 5 business

days after Kick-off Meeting.

COR

4.1.3 Draft Weekly Project Meeting

Agendas.

MS Word 2 business days prior to each weekly meeting.

COR

4.1.3 Weekly Project Meeting Minutes. MS Word 3 business days after each weekly project meeting.

COR

4.1.4 Demonstrations. WebEx 3 demonstrations

during period of performance of the contract.

4.2.1 Updated version of Athena 2.0.6. ULM

Diagram and

MATLAB

Code in the form of .m files

17 months from date of award.

COR

4.2.2 Computer Code Documentation for

updating and improving Athena 2.0.x.

ULM

Diagram and

MATLAB

17 months from date of award.

COR

Code in the form of .m files

4.2.2 User Documentation (Reference

manuals and User Guides).

PDF 17 months from date of award.

COR

6. INSPECTION AND ACCEPTANCE CRITERIA

The Government’s Contracting Officer’s Representative (COR) is a duly authorized representative of the Government and is responsible for inspection and acceptance of all items to be delivered under this contract. Unless otherwise specified by the COR, the general quality measures, as set forth below, will be applied to each work product received from the Contractor under this contract.

Accuracy: Work Products shall be accurate in presentation, technical content, and adherence to MATLAB programing style guidelines.

Clarity: Work products shall be clear and concise. Diagrams shall be clearly written using plain language principles such that both expert and non-experts can understand and execute the code/application. End-users include non-expert and expert users of MATLAB.

Consistency to Requirements: All work products must satisfy the requirements of this

SOW.

Timeliness: Work products shall be submitted as described in assigned tasks or submitted in accordance with a scheduled date determined by or approved by the Government.

Acceptance may be presumed unless otherwise indicated in writing by the COR within 30 calendar days of receipt.

7. CONTRACTOR PERFORMANCE

Performance measures designed to measure the Contractor’s effectiveness will be utilized. The Contractor’s performance shall be evaluated at the end of the period of performance. Baseline acceptable quality thresholds are presented in the table below for all deliverables and services provided throughout the period of performance. This evaluation shall become a part of the file and shall be used as past performance information in evaluating the Contractor’s past performance on future contracts. The Contractor shall be given a minimum of 30 business days to submit comments, rebutting statements, or additional information. All evaluation will be performed by the Contracting Officer’s Representative and/or Contracting Officer.

Please note the Contractor shall be evaluated based on the Performance Matrix table noted below.

SOW

Item

Description Performance Standard

Acceptable Quality Level Surveillance Method & Assessment

All Tasks

Project Management

Management of project resources and budget to ensure the requirements of the SOW for the contract are completed.

Project activities are completed as specified in the project management report/deliverables table.

100% Inspection

All Tasks

Quality and Timeliness of Deliverables

Deliverables are on time per the deliverables table in Section 5 of this contract.

Deliverables are delivered to the COR as specified in the deliverables table in Section 5 by the specified date in the deliverables table of this contract.

100% Inspection

Task 4.2.1

Quality Code Delivered into the

MATLAB

Software

All new or modified code is thoroughly inspected and tested with respect to the functionality of the graphical user interface.

Enhanced code passes the validation testing without incident.

100% Inspection

Acceptable surveillance methods include:

100 Percent Inspection - With this method, performance is inspected/ evaluated at each occurrence. This method is often costly but can be necessary due to health, safety and other considerations.

8. CONTRACTOR PERFORMANCE EVALUATION

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at https://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the Contractor in

CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the Contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and Contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/webtrain_auto.htm. There is no fee for registration or use of the CPARS.

9. PERIOD OF PERFORMANCE

The period of performance shall be 18 months from the date of award.

10. PLACE OF PERFORMANCE

The place of performance for this contract shall be at the Contractor’s site.

11. HOURS OF OPERATION AND CLOSINGS

Normal business hours will be Monday through Friday, 8:00 AM to 6:00 PM Eastern Time (ET).

For unscheduled closings, (e.g., weather emergencies, Executive Orders, etc.) the Contractor shall seek guidance from the COR.

The Government is closed on the holidays listed below. Specific dates for these holidays can be found at the Office of Personnel Management (OPM) website located at:

http://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/

New Year’s Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Any other day designated by Federal statute Any other day designated by Executive Order Any other day designated by the President

The Contractor will not charge any holiday as a direct charge to the contract. In the event Con-tractor personnel work during a holiday observed by the Contractor other than those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost.

Contractor personnel are not authorized and shall not invoice the Government for administrative leave.

12. CONTRACT TYPE

This is a labor-hour contract.

13. STAFFING

The Contractor shall be responsible for providing personnel with the management, technical, and subject matter expertise required to accomplish the activities and prepare the deliverables identified in this SOW.

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the requisite experience, and are otherwise fully qualified to provide the high level of support required by this SOW prior to being assigned to this contract. The Contractor shall possess in-depth and thorough understanding of the MATLAB development environment for the design of complex software applications in MATLAB OOP, including an in-depth understanding of MATLAB OOP to accurately implement models associated with real world problems in tobacco research and regulation. The Contractor shall demonstrate clear and in-depth understanding on how MATLAB can implement matrix manipulations, implementation of algorithms, creation of user interfaces, and interfacing MATLAB with programs written in other languages, including: R, Python, Java, FORTRAN, C, and C++. The Contractor shall have acquired sufficient knowledge of MATLAB to take advantage of its high-performance numerical computation capabilities, data analysis features, and visualization capabilities. These knowledge/experience requirements are delineated in the key personnel labor category descriptions below in Section 13.1.

The Contractor shall ensure that all Contractor support personnel are ready to work, no later than two (2) weeks after the contract award date.

13.1 Key Personnel

Pursuant to HHSAR clause 352.270-5: Key Personnel, the labor categories listed described below shall be considered key under this contract. At least 30 calendar days prior to diverting any of the key personnel from this contract (or as soon as possible, if an individual must be replaced), the Contractor shall notify the Contracting Officer Representative (COR) and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer (CO).

IT Project Manager MATLAB Software Engineer I MATLAB Software Engineer II MATLAB Software Modeler I MATLAB Software Modeler II MATLAB Software Programmer I MATLAB Software Programmer II

Necessary skills and experience for the each of the above key personnel include the following:

IT Project Manager

The IT Project manager shall have experience with coordination and timely completion of projects, as well as experience overseeing all aspects of projects, setting deadlines, assigning responsibilities, monitoring and summarizing progress of project. The project manager shall have skills in formulating, communicating, and enforcing quality work standards. The IT Project Manager shall have proven ability to monitor progress and resolve any identified issues impacting upon successful product delivery, and proven ability to ensure compliance with all administrative and contractual requirements. Experience working with Federal or State government (preferred).

MATLAB Software Engineer I

The MATLAB Software Engineer I will work with the MATLAB Software Programmers and MATLAB Modelers to design, build, validate, and implement modeling frameworks. The MATLAB Engineer I, in conjunction with other staff, will be responsible for addressing technical problems that arise in implementing modeling frameworks. The MATLAB Software Engineer I is recognized as a key contributor. The MATLAB Software Engineer I works with minimal supervision and technical guidance. Directs and oversees the work of the MATLAB Software Engineer II position. The MATLAB Engineer I participates in monthly and weekly project meetings with FDA staff that discuss the development and implementation of modeling frameworks. MATLAB Software Engineer I shall have at least seven (7) years’ experience with MATLAB. The MATLAB Software Engineer I shall demonstrate experience focusing in the use of MATLAB OOP for the development and maintenance of large computer applications.

Experience includes programing and use of MATLAB toolboxes, such as Simulink, for the implementation of system dynamic models in MATLAB.

MATLAB Software Engineer II

The MATLAB Software Engineer II will assist the MATLAB Software Engineer I in the design, building, and development of modeling frameworks. The MATLAB Software Engineer II will work on the development of modeling frameworks. The MATLAB Engineer II, in conjunction with other staff, will be responsible for assisting in addressing technical problems that arise in implementing modeling frameworks. The MATLAB Software Engineer II works with supervision and technical guidance from the MATLAB Software Engineer I. MATLAB Software Engineer II shall have experience with MATLAB. The MATLAB Software Engineer II shall demonstrate experience focusing in the use of OOP for the development of computer applications. Example experience includes MATLAB OOP, and other Object-Oriented programing languages such as Java, C, and Python.

MATLAB Software Modeler I

The MATLAB Software Modeler I will work with the MATLAB Software Engineers and MATLAB Software Programmers to design, build, validate, and implement modeling frameworks.

The MATLAB Software Modeler I will be tasked with developing the scientific basis underlying implementation of the modeling frameworks. The MATLAB Software Modeler I, in conjunction with other staff, will be responsible for the scientific rationale underlying modeling frameworks.

The MATLAB Software Modeler I is recognized as a key contributor. The MATLAB Software Modeler I works with minimal supervision and technical guidance. Directs and oversees the work of the MATLAB Software Modeler II position. The MATLAB Software Modeler I participates in the monthly and weekly project meetings with FDA staff to discuss the development and implementation of modeling frameworks. MATLAB Software Modeler I shall have at least seven (7) years’ experience with MATLAB and building models. The MATLAB Software Modeler I shall demonstrate experience in the use of modeling and simulation of virtual representation of real-world systems driven by mathematical relationship using MATLAB and its suite of toolboxes.

Example experience includes developing representations of real-world systems using schematically diagrams in Simulink.

MATLAB Software Modeler II

The MATLAB Software Modeler II will assist the MATLAB Software Modeler I in the design, building, validating, and implementation of modeling frameworks. The MATLAB Software Modeler II will assist in the development of the scientific basis underlying implementation of the modeling frameworks. The MATLAB Software Modeler II, in conjunction with other staff, will be responsible for the scientific rationale underlying modeling frameworks. The MATLAB Software Modeler II works with supervision and technical guidance from the MATLAB Software Modeler I. MATLAB Software Modeler II shall have experience with MATLAB and building models.

MATLAB Software Programmer I

The MATLAB Software Programmer I will work with the MATLAB Software Engineers and MATLAB Software Modelers to design, build, validate, and implement modeling frameworks.

The MATLAB Software Programmer I will be tasked with developing the computer code that will be used in implementing the modeling frameworks. The MATLAB Software Programmer I, in conjunction with other staff, will be responsible for addressing technical problems that arise in implementing modeling frameworks. The MATLAB Software Programmer I is recognized as a key contributor. The MATLAB Software Programmer I works with minimal supervision and technical guidance. Directs and oversees the work of the MATLAB Software Programmer II position. The MATLAB Software Programmer I participates in the monthly and weekly project meetings with FDA staff to discuss the development and implementation of modeling frameworks.

MATLAB Software Programmer I shall have at least seven (7) years of experience with MATLAB.

The MATLAB Software Programmer I shall demonstrate experience in the fundamental of MATLAB programing and use. Example experience includes use and knowledge of ULM and the use of MATLAB for data analysis and visualization.

MATLAB Software Programmer II

The MATLAB Software Programmer II will assist the MATLAB Software Programmer I in the design, building, validating, and implementation of modeling frameworks. The MATLAB Software Programmer II will assist in the development of the computer code that will be used in implementing the modeling frameworks. The MATLAB Software Programmer II, in conjunction with other staff, will be responsible for assisting in addressing technical problems that arise in implementing modeling frameworks. The MATLAB Software Programmer II works with supervision and technical guidance from the MATLAB Software Programmer I. MATLAB Software Programmer II shall have experience with MATLAB. The MATLAB Software Programmer II shall have experience in the fundamental of MATLAB programing and use.

Example experience includes using the MATLAB Interface to write basic functions and scripts files, manipulate datasets, and creating graphics.

14.1 Section 508 Requirements

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase information and communication technologies (ICT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of information and communication technology (ICT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Section 508 standards apply to the content identified in this SOW:

E101.2-Equivalent Facilitation (Appendix A, Application and Scoping Requirements).

E203-Access to Functionality (Appendix A, Application and Scoping Requirements).

E204-Functional Performance Criteria (Appendix A, Application and Scoping

Requirements).

E205-Electronic Content (Appendix A, Application and Scoping Requirements).

302-Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements).

E208-Support Documentation and Services (Appendix A, Application and Scoping

Requirements).

Chapter 6-Support Documentation (Appendix C, Functional Performance Criteria and

Technical Requirements).

15. GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO):

Brendan McCarthy 5630 Fishers Lane, Office #2099 Rockville, MD 20857 Brendan.McCarthy@fda.hhs.gov

(240) 402-7540

Contract Specialist (CS):

Daniel Rich 5630 Fishers Lane, Office #2087 Rockville, MD 20857 Daniel.Rich1@fda.hhs.gov

(240) 402-1295

Contracting Officer’s Representative (COR):

[TBD]

16. CONTRACTING OFFICER AUTHORITY

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this contract and notwithstanding any provisions contained elsewhere in the contract, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the contract terms and con-ditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract and modify any term or condition of the contract.

The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the contract price, terms or conditions. The COR/Project Officer is responsible for the technical as-pects of the project and serves as technical liaison with the Contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the contract.

17. ORGANIZATION CONFLICT OF INTEREST

The warrant and disclosure requirements in this clause apply to both the Contractor and all subcontractors. The Contractor warrants that, to the best of the Contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the Contractor has disclosed all relevant information regarding any actual or potential conflict related to this contract. The Contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the Contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage if such conflict arises during the performance of this contract. Such disclosure shall include a description of the actions the Contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest. If the Contractor or subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated to the satisfaction of the Contracting Officer, the Contractor must obtain the written approval of the Contracting Officer prior to entering into this contract.

If the Contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

18. CLAUSES

18.1 Federal Acquisition Regulation (FAR) Clauses

FAR 52.252-2: Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text avail-able. Also, the full text of a clause may be accessed electronically at this address:

http://farsite.hill.af.mil/vffara.htm.

(End of Clause)

FAR 52.203-19: Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) FAR 52.204-18: Commercial and Government Entity Code Maintenance (Jul 2016) FAR 52.212-4: Contract Terms and Conditions -- Commercial Items (Jan 2017) FAR 52.227-14: Rights in Data – General (May 2014) FAR 52.232-7: Payments Under Time-and-Materials and Labor-Hour Contracts (Aug 2012) FAR 52.232-39: Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.232-40: Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

FAR 52.212-5: Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Aug 2018)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Fur-ther Continuing Appropriations Act 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Devel-oped or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(4) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(5) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Rein-vestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

_X_ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved]

_X_ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111- 117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Con-tractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).

_X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

___ (10) [Reserved]

___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

_X_ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Busi-ness Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved]

___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C.

644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C.

637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Nov 2016) of 52.219-9.

___ (iii) Alternate II (Nov 2016) of 52.219-9.

___ (iv) Alternate III (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Aug 2018) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (Nov 2011) (15 U.S.C. 657f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C.

637(m)).

___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

___ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

___ (ii) Alternate I (Feb 1999) of 52.222-26.

_X_ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222-35.

_X_ (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

___ (ii) Alternate I (July 2014) of 52.222-36.

_X_ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

_X_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Rela-tions Act (Dec 2010) (E.O. 13496).

_X_ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).

_X_ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA- Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acqui-sition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equip-ment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (38) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

___ (ii) Alternate I (Oct 2015) of 52.223-13.

___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (41) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driv-ing (Aug 2011) (E.O. 13513).

___ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13696).

___ (45) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

___ (ii) Alternate I (Jan 2017) of 52.224-3.

___ (46) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (47) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

___ (ii) Alternate I (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III (May 2014) of 52.225-3.

___ (48) 52.225-5, Trade…